MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-28 for NASALCARE NASALCLEANSE KIT manufactured by Techworld Corporation, Inc.
[5598795]
We purchased a nasalcare nasalcleanse kit online. Then we found there are some small parts could be danger to our little kids. Then we tried to call the toll free # on the package 1888-658-8108. There was no one answer the phone but asked us to got to (b)(6). But the product was manufactured by (b)(6). We checked (b)(6) state website, there is no such as techworld medicals, inc (b)(6)! We don't know what is going on here.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041803 |
| MDR Report Key | 4652354 |
| Date Received | 2015-03-28 |
| Date of Report | 2015-03-28 |
| Date Added to Maude | 2015-04-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASALCARE NASALCLEANSE KIT |
| Generic Name | NASALCARE NASALCLEANSE KIT |
| Product Code | KMA |
| Date Received | 2015-03-28 |
| Lot Number | 8355120 |
| Device Expiration Date | 2018-06-30 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECHWORLD CORPORATION, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-03-28 |